JP2016532461A - Labeling implantable medical device - Google Patents

Abstract

In general, techniques for labeling an implantable medical device (IMD) are described. In one example, the IMD includes a housing that contains electronic circuitry. The IMD can include a header connected to the housing and includes a core. The core defines a hole and includes a first metal label disposed adjacent to the at least one hole. The IMD includes a lead assembly including at least one lead having a distal end and a proximal end, the at least one lead includes a second metal label, and the distal end includes at least one electrode; The proximal end is received in the hole.

Description

  The present invention relates to medical devices, and more particularly to labels for implantable medical devices.

  Implantable medical devices (IMDs) perform various diagnostic or therapeutic functions. In one example, the IMD has cardiac function management properties such as monitoring the heart or providing electrical stimulation to the heart or nervous system. Cardiac function management characteristics are used, for example, to diagnose or treat a patient during an electrical or mechanical abnormality of the heart. Examples of IMD are in particular pacemakers, automatic implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, implantable monitors, neuromodulators (eg deep brain stimulators or other neurostimulators) , Transplant cochlear stimulator, drug pump and so on.

  Such IMDs include housing-borne electronic circuitry that is configured to wirelessly transfer information between implanted IMDs or between an IMD and an assembly outside the body. Such information includes, for example, programming instructions or configuration information that configures the IMD to monitor, diagnose, or treat a physiological condition. The information also includes data (eg, physiological information, disease state, etc.) that is sensed, detected, or processed by the IMD and transmitted to another device or assembly. The electrode is connected to the housing through a connection portion called a header. Headers and lead wires are standardized. The header includes a relatively deep female receptacle (eg, a hole) having several contact surfaces, and the lead includes a male portion having a generally circular contact surface on one or more corresponding perimeters. Each lead has a designated hole, and if the lead is inserted into an incorrect hole in the header, the IMD may malfunction after implantation.

  The lead wire is electrically connected to the electronics of the housing via a contact wire extending from the housing. The number of contact wires can vary and the risk of wire crossing increases as the number of contact wires increases. Incorrect lead-to-hole connections and wire crossings can cause various errors such as false ventricular stimulation or sensing, incomplete or intermittent connectivity between lead and IMD, ineffective defibrillation therapy, etc. There is a risk of causing. Correcting the error may extend the treatment time. In some cases, error correction may require subsequent surgical correction, increasing the patient's risk of morbidity and mortality.

  It is an object of the present invention to provide a label for a medical device, particularly an implantable medical device.

  In general, an implantable medical device (IMD) includes a pacemaker, a defibrillator, a cardiac resynchronization therapy device, a nerve stimulation device, an implantable monitoring device, or a device. The IMD generates electrical stimulation that is delivered to the desired tissue site. Electrical stimulation is provided through electrodes having a portion of the implantable lead assembly. The lead wire assembly is mechanically and electrically coupled to the IMD to interface with circuitry contained in the IMD.

  In particular, the inventors have noted that increasing the lead wire or electrode structure may complicate the connection between the lead wire and the IMD and the connection between the electronic circuit housed in the housing and the lead wire. . For example, each lead wire is coupled to the IMD so as to be electrically coupled to a corresponding circuit housed in the housing. In order to reduce the risk of lead and header misconnection and circuit misconnection, the present inventors have provided a low cost, biocompatible labeling system and method.

  Conventional approaches incorporate ink that labels the various components of the IMD. However, the ink undergoes a rigorous biocompatibility test to incorporate the ink used with the IMD. The complexity of ink and pigment systems can increase the cost of biocompatibility verification and product validation. Continuous monitoring of ink and pigment purity can also increase the cost of providing a labeling system for the IMD.

  Various embodiments of the present disclosure provide a biocompatible color code and string labeling system for IMD. For example, a biocompatible metal colors the surface by anodizing without changing the biocompatibility of the material. Anodization of the biocompatible metal maintains the compatibility of the biocompatible metal in biomedical applications without compromising the integrity or properties of the biocompatible metal. In one example, the biocompatible metal is anodized to provide a string on the surface that helps label the IMD components. Giving colors and strings to the various components of the IMD helps identify the parts and reduces the risk of incorrect manufacturing, assembly and implantation of the IMD. This benefit is beneficial in surgical applications and complex IMD assembly.

  The present disclosure labels an IMD by including a biocompatible metal substrate that is anodized to provide an identifier that includes at least one of a color and a string. Anodized biocompatible metal substrates are biocompatible and reduce the risk of assembly errors such as wire crossing or lead misconnection. The labels and methods described herein eliminate unstable components (eg, ink) and eliminate biocompatibility risks using other labeling methods. Also, the IMD and methods described herein are flexible in manufacturing and inexpensive to implant.

1 is a schematic diagram illustrating an example of a system that includes an IMD. FIG. 2 is a close-up view schematically illustrating a portion of the example IMD of FIG. 1. It is a perspective view which shows the example of the core of IMD of FIG. It is a side view which shows the example of the core of FIG. 3A. It is a perspective view which shows an example of the header containing the core of FIG. 3A. It is a perspective view which shows an example of the core of IMD of FIG. It is a side view which shows the example of the core of FIG. 5A. It is a perspective view which shows an example of the lead wire assembly of IMD12. It is a perspective view which shows an example of the header and housing of IMD12. 1 schematically illustrates an example of a method for labeling an implantable medical device. 1 schematically illustrates an example of a method for labeling an implantable medical device.

  FIG. 1 schematically illustrates an example of a system 10 that includes an implantable medical device (IMD) 12 implanted in a body (eg, a patient 14) that is wirelessly connected to an external module 16. In one example, the IMD 12 includes an implantable device housing 18 that includes a conductive portion (eg, a hermetically sealed titanium housing, or a housing that includes other materials), a header 22, and an implantable lead assembly 24. The header 22 mechanically and electrically connects the implantable lead assembly 24 to the housing 18 and the electrical circuitry contained within the housing 18.

  In one example, the IMD 12 connects to an implantable lead assembly, such as a lead assembly 24 that can be delivered into a blood vessel. The lead assembly 24 is configured to provide electrical stimulation to a site on, within, or in the vicinity of the heart 26. For example, the lead wire assembly 24 includes a plurality of lead wires 27A, 27B, and 27C (collectively referred to as “lead wires 27”). Lead wire 27 includes an electrode.

  For example, the lead wire 27A includes an electrode 28 associated with the right chamber 36, such as a tip electrode and / or a ring electrode. Inserting an electrode into a specific ventricle, inserting an electrode into a portion of the cardiovascular system in the vicinity of a specific ventricle, placing an electrode in the epicardium outside a specific ventricle, or sensing a signal and / or Alternatively, electrode 28 is “associated” with a particular ventricle by any other technique for configuring or placing an electrode that provides treatment to the ventricle. Lead wire 27B includes an electrode 30 associated with right atrium 32, such as a tip electrode and / or a ring electrode. A lead 27C that can be inserted into the coronary sinus and / or the cardiac vena cava or one of its branches includes an electrode 29 associated with the left ventricle 34, such as a tip electrode and / or a ring electrode. The example of FIG. 1 includes three leads configured to be placed in the heart, but the number and location of the leads will vary depending on the type of treatment provided and the type of IMD.

  In one example, the IMD 12 includes electrodes disposed on the housing 18 of the IMD 12, such as housing electrodes 38 and / or header electrodes 42, which electrodes are at least of the electrodes 28, 29, 30 associated with the heart 26. Together with one, it is particularly useful for monopolar sensing of cardiac signals and unipolar delivery of contractile stimuli.

  The housing 18 houses at least a portion of the implantable circuit 20, such as a transmitter, receiver, or transceiver. In one example, the IMD 12 includes a header 22 that is configured to mechanically and electrically connect the lead assembly 24 to the implantable circuit 20 of the housing 18. The IMD 12 includes an antenna in the header 22 that is configured to electromagnetically and wirelessly transfer information to the external module 16. In one example, the external module 16 includes an external antenna connected to an external telemetry circuit.

  In one example, external module 16 is a physician programmer, clinical monitor, or comparison used to transfer programming instructions or configuration information to IMD 12 or receive diagnostic information, disease state, information about physiological parameters, etc. from IMD 12. Includes near-neighbor assemblies. The external module 16 can communicate with other external assemblies such as remote external assemblies located elsewhere (eg, servers, client terminals such as web-connected personal computers, cellular base stations, or other wireless or wired remote assemblies). Connect to.

  As described in this specification, when the lead wire and electrode structure increase, the connection between the lead wire 27 and the housing 18 via the header 22 may be complicated. In the example of FIG. 1, the header 22 can include header labels 40A-C (collectively referred to herein as “header labels 40”), and the lead wire 27 includes lead wire labels 41A-C (herein. Collectively referred to as “lead wire label 41”). The header and lead labels 40 and 41 are formed from a biocompatible material such as a biocompatible metal substrate. For example, the header and lead labels 40, 41 are formed from titanium, tantalum, tungsten, stainless steel, nitinol, cobalt chrome alloy, palladium, platinum, or other noble metals. The biocompatible metal substrate is anodized to include the identifier. The identifier includes at least one of a color and a character string. Headers and lead labels 40 and 41, including identifiers (eg, at least one of color and text), assist in the manufacture, assembly, and implantation of the IMD 12.

  FIG. 2 schematically illustrates an example of the IMD 12 of FIG. The IMD 12 includes a housing 18, a header 22, and a lead wire assembly 24. In one example, the header 22 includes a core 48 located within a header housing 46. The header housing 46 and the core 48 define holes 50A-C (collectively referred to as “holes 50”). As shown in FIG. 2, each lead wire 27A-C is disposed in a corresponding hole 50A-C. For example, the lead wire 27A is disposed in the hole 50A, the lead wire 27B is disposed in the hole 50B, and the lead wire 27C is disposed in the hole 50C. Header label 40 and lead label 41 provide visual assistance to reduce the risk of accidentally connecting lead 27 to header 22.

  In one example, the core 48 is formed from a dielectric material such as polyurethane, polyetheretherketone, epoxy, or other material. In one example, the header housing 46 is translucent and is formed from a dielectric material. Since the header housing 26 is translucent, the header label 40 is visible through the header housing 46.

  In one example, header labels 40A-C are each anodized to provide an anodized metal label that includes an identifier. Anodizing involves growing an oxide layer on the surface, producing a range of different colors. Anodization is further described herein. Each identifier of the header labels 40A to 40C substantially matches the identifier of the corresponding header label of the header label 40. Each header label 40A-C is placed adjacent to a corresponding hole in holes 50A-C and visually indicates the relationship with a particular hole. In one example, the header label 40A is associated with the hole 50A. The header label 40A is arranged on the core 48 at a position adjacent to the hole 50A so as to be associated with the hole 50A and show the relationship. In one example, the header label 40B is associated with the hole 50B, and the header label 40C is associated with the hole 50C.

  As shown in the example of FIG. 2, a lead 27A configured to be connected to the housing 18 through a hole 50A includes a lead label 40A having an identifier that substantially matches the identifier of the header label 40A. The lead wire 27A is accurately connected to the housing 18 through the hole 50A. In one example, the identifiers of the header label 40A and the lead wire label 41A are color. That is, the color 51 is provided by anodizing the surface of the header label 40A and the surface of the lead wire label 41A. In one example, the color 51 is red. Therefore, the operator can easily visually recognize that the lead wire 27A (for example, having the color 51) is connected to the housing 18 through the hole 50A (for example, having the color 51) of the core 48.

  In one example, the header label 40B is associated with the hole 50B. The lead wire 27B is connected to the housing 18 through the hole 50B. The header label 40B and the lead wire label 41B include the same identifier. For example, the surface of header label 40B and the surface of lead wire label 41B are anodized to provide color 52. In one example, color 52 is different from color 51. In one example, color 51 is red and color 52 is blue. Therefore, the operator easily visually recognizes that the lead wire 27B (for example, having the color 52) is connected to the housing 18 through the hole 50B (for example, having the color 52).

  In one example, the header label 40C is associated with the hole 50C. The lead wire 27C is connected to the housing 18 through the hole 50C. The header label 40C and the lead wire label 41C include the same identifier. For example, the surface of header label 40C and the surface of lead wire label 41C are anodized to provide color 53. In one example, color 53 is different from color 51 and color 52. For example, color 51 is red, color 52 is blue, and color 53 is yellow. Therefore, the operator can easily visually recognize that the lead wire 27C (for example, having the color 53) is connected to the housing 18 through the hole 50C (for example, having the color 53).

  The header label 40 and the lead wire label 41 are provided using various biocompatible metals. As described herein, anodizing a biocompatible metal provides a range of colors. For example, a biocompatible metal can be anodized to provide a color including but not limited to black, gray, brown, purple, blue, yellow, red, orange, green.

  In one example, the header label 40 is anodized to provide a string that can further assist in reducing the risk of incorrect assembly, manufacture, and implantation of the IMD 12. After the header label 40 is anodized to include a color (eg, background color), the header label 40 is provided with a string. As shown in the example of FIG. 2, the header label 40 </ b> A is anodized to provide a character string such as “RV” 43. As shown in FIG. 1, the lead wire 27 </ b> A is configured to be associated with the right ventricle of the heart 26. Thus, the string “RV” 43 helps the surgeon in implanting the IMD 12. The character string “RV” 43 is black in comparison with the color 51 of the header label 40A. Header label 40B includes a string “RA” 44 indicating that lead 27B is configured to be inserted into the right atrium. Furthermore, the header label 40C includes a character string “LV” indicating that the lead wire 27C is configured to be inserted into the left ventricle. In one example, the lead wire labels 41A to 41C can be changed to include a character string. In one example, the string includes letters, numbers, symbols, and / or other graphics.

  Anodizing the biocompatible metal substrate to provide a color and a character string is performed by at least one of an electrochemical anodizing method and a LASER anodizing method. In one example, the color is provided using an electrochemical anodization method and the string is provided using a LASER anodization method. In the electrochemical anodization method, an oxide layer is electrochemically grown on the surface of the biocompatible metal substrate to form a header label 40 and a lead wire label 41 including a first identifier (for example, color). For example, a voltage is applied to an electrolytic cell containing components to include color. The applied voltage controls the thickness of the oxide layer and determines the color produced in the component.

  LASER anodization involves growing an oxide layer on the surface of a biocompatible metal substrate by laser treatment. For example, the oxide layer is grown to a precise thickness based on laser heating in an oxygen-containing atmosphere. In one example, the color is provided using either electrochemical anodization or LASER anodization. In one example, an electrochemical anodization method is used to provide color, and a LASER anodization method is used to provide a string.

  In the example of FIG. 2, the header labels 40A to 40C are square. However, the shapes of the header labels 40A to 40C include other shapes. For example, the shapes of the header labels 40A to 40C are modified to be different from each other so that the header labels 40A to 40C can be distinguished. In one example, the header label 40A is square, the header label 40B is triangular, and the header label 40C is circular.

  3A is a perspective view showing an example of the core 48 of the IMD 12 of FIG. The core 48 includes an upper surface 54, a lower surface 56, and two side wall surfaces 64 and 66. The first surface 60 and the second surface 62 extend between the upper surface 54, the lower surface 56, and the two side wall surfaces 64, 66. The core 48 includes holes 50 </ b> A to 50 </ b> C that extend from the first side wall surface 64 toward the second side wall surface 66. The core 48 includes a plurality of connector block openings 68 that house connector blocks (shown as connector blocks 104A-B, 106A-D, 108 in FIG. 7). The connector block opening 68 extends from the first surface 60 to the second surface 62 of the core 48. In another example, one or more of the plurality of connector block openings 68 extend into the core 48. The connector block opening 68 communicates with the holes 50A-C so that when inserted into the connector block opening 68, the connector block interfaces with the contact surfaces of the lead wires 27A-C.

  In the example of FIG. 3A, the core 48 includes receiving voids 70 </ b> A-C along the first side wall 64 of the core 38. The receiving cavities 70A-C can be slots that extend to the first side wall 64 of the core 48 and are configured to receive the header labels 40A-C. For example, the header labels 40A to 40C are metal substrates having dimensions and shapes that are inserted into the accommodation gaps 70A to 70C. The core 48 includes windows 72A-C communicating with the accommodation voids 70A-C. For example, when the header labels 40A to 40C are inserted into the accommodation gaps 70A to 70C, a part of the surface of the header labels 40A to 40C becomes visible through the windows 72A to 72C. The receiving cavities 70A-C have a larger area than the windows 72A-C and provide initial stability when a metal substrate (eg, before anodization or empty) is inserted into the receiving cavities 70A-C. As described herein, the header labels 40A-C are anodized before insertion into the accommodation gaps 70A-C or after insertion into the accommodation gaps 70A-C. In one example, the header labels 40A-C can be anodized prior to insertion into the receiving cavities 70A-C, and after insertion of the header labels 40A-C into the receiving cavities 70A-C, a string (as illustrated herein). 2) is provided to header labels 40A-C.

  FIG. 3B is a side view showing an example of the core 48 of FIG. 3A. In the example shown in FIG. 3B, the accommodation voids 70A to 70C are disposed adjacent to the holes 50A to 50C. For example, the accommodation void 70A is disposed adjacent to the hole 50A, the accommodation void 70B is disposed adjacent to the hole 50B, and the accommodation void 70C is disposed adjacent to the hole 50C. In other words, the accommodation void 70A is disposed closer to the hole 50A than the hole 50B or 50C, the accommodation void 70B is disposed closer to the hole 50B than the hole 50A or 50C, and the accommodation void 70C is more hole than the hole 50A or 50B. Located near 50C.

  FIG. 4 is a perspective view showing an example of the header 22 of the IMD 12. The header 22 includes a core 48 (shown in FIGS. 3A and 3B) and a header housing 46. The header housing 46 is overmolded to the core 48. Header housing 46 and core 48 define holes 50A-C configured to receive lead wires 27A-C (shown in FIGS. 1 and 2). In the example of FIG. 4, header labels 40A-C are disposed within the accommodation gap (shown as 70A-C in FIG. 3B). In one example, header labels 40A-C are square metal substrates having a surface area greater than the area of windows 72A-C. Providing header labels 40A-C with a larger surface area than windows 72A-C ensures header labels 40A-C in the core prior to anodization and / or overmolding (e.g., for color and / or string) To place.

  In one example, the header labels 40A-C can be inserted into the receiving gaps 70A-C as empty metal substrates and are anodized after insertion into the core 48 (eg, to include color and character strings). In another example, the header labels 40A-C are anodized (e.g., so as to include color and character strings) prior to insertion into the receiving voids 70A-C.

  In one example, header labels 40A-C can be anodized prior to insertion into receiving voids 70A-C to provide a first identifier (eg, color) and anodized after insertion into receiving voids 70A-C. To provide a second identifier (eg, a character string). For example, header label 40A can be anodized to include color 51, header label 40B can be anodized to include color 52, and header label 40C can be anodized to include color 53. After the color is added to each of the header labels 40A-C, the header labels 40A-C are inserted into the receiving gaps 70A-C. In the example in which the character string is provided, the header labels 40A to C are inserted into the accommodating gaps 70A to 70C, and then the character strings are provided to the header labels 40A to 40C. For example, the header labels 40A to 40C are anodized so as to include character strings. For example, after the header labels 40A-C are inserted into the accommodation gaps 70A-C, the character strings “RA”, “LV”, “RV” are provided to the header labels 40A-C. In this way, the character string is always visible through the windows 72A to 72C. In one example, a first identifier (eg, color) is added to header labels 40A-C prior to a second identifier (eg, a string).

  In one example, the header labels 40A-C can have larger dimensions than the windows 72A-C and are inserted into the receiving gap. In one example, the windows 72A-C can be a containment gap and the header labels 40A-C are placed in the windows 72A-C. For example, since the header labels 40A to 40C are substantially the same as the windows 72A to 72C, the header labels 40A to 40C are placed in the windows 72A to 72C serving as receiving spaces. In another example, the core 48 does not include a containment gap and the header labels 40A-C are coupled to the first surface 60 of the core 48 by, for example, a biocompatible adhesive.

  FIG. 5A is a perspective view showing an example of the core 48 of the IMD of FIG. Although header labels 40A-C in FIG. 4 are shown as separate and independent labels, FIG. 5A shows an example of a core 48 that includes a single header label 74. FIG. For example, the core 48 includes a single containment cavity 76 (shown in FIG. 5B) along the first sidewall 64. The header label 74 is inserted into the accommodation gap 76 so that a part of the header label 74 can be seen through the windows 72A to 72C. In the header label 74, the portion 78 of the header label 74 adjacent to the hole 50A has a color 51, the portion 80 of the header label 74 adjacent to the hole 50B has a color 52, and the header label 74 adjacent to the hole 50C The portion 82 is selectively anodized to have a color 53. In one example, the portions 78, 80, 82 are anodized to include character strings. For example, portion 78 includes the string “RV”, portion 80 includes the string “RA”, and portion 82 includes the string “LV”.

  FIG. 6 is a perspective view showing an example of the lead wire assembly 24 of the IMD 12. As described herein, IMD 12 includes a lead assembly, such as lead assembly 24. Lead wire assembly 24 includes lead wires 27A-C. Leads 27A-C include a distal end 84 and a proximal end 86. Distal end 84 includes an electrode configured to provide treatment to adjacent tissue. For example, the lead wire 27 </ b> A can include the electrode 29, the lead wire 27 </ b> B can include the electrode 30, and the lead wire 27 </ b> C includes the lead wire 29. In one example, proximal end 86 includes lead labels 41A-C as described herein.

  Lead wire labels 41A-C are formed from a biocompatible material. For example, the lead labels 41A-C are formed from a biocompatible metal such as titanium, tantalum, tungsten, stainless steel, nitinol, cobalt chromium alloy, palladium, platinum, or other noble metals. Each of the lead label 41A-C includes an identifier. For example, the identifier includes at least one of a color and a character string. In the example of FIG. 4, the lead wire label 41A is anodized to have a color 51, the lead wire label 41B is anodized to have a color 52, and the lead wire label 41C is anodized to have a color 53. Oxidize.

  In one example, the lead wire labels 41A to 41C are annular rings arranged around the outer surface 100 of the lead wires 27A to 27C. In one example, the lead wire labels 41A-C are tightly fitted to the lead wires 27A-C. For example, the lead wire label is caulked to the lead wires 27A to 27C. The portions of the lead wires 27A-C including the lead wire labels 41A-C arranged around the outer surface are overmolded with a transparent polymer material, and the smooth outer surface 100 with the identifier (eg color or character string) visible. I will provide a.

  In one example, the lead wire labels 41A-C are integrated with the main body of the lead wires 27A-C. For example, an annular metal ring is anodized and formed of a transparent polymer material on the lead body.

  The proximal end 86 of the leads 27A-C includes a proximal portion 88A-C that is configured to be received within the holes 50A-C of the header 22 (shown in FIG. 2). Proximal portions 88A-C include a connector block in the core as described herein and a contact surface configured to contact the tip. For example, lead 27A includes a portion 88A configured to be received within hole 50A (shown in FIG. 2). Portion 88A includes a tip contact 94 and contact rings 90A and 90B. Lead wire 27B includes a portion 88B configured to be received in hole 50B (shown in FIG. 2). Portion 88B includes a tip contact 96 and contact rings 91A and 91B. Lead wire 27C includes a portion 88C configured to be received in hole 50C (shown in FIG. 2). Portion 88C includes a tip contact 98 and contact rings 92A and 92B. Portions 88A-C each include two contact rings and one tip contact, although other configurations are possible. For example, portions 88A-C each include 1-3 ring contacts and one tip contact.

  Tip contacts 94, 96, 98 and contact rings 90A, 90B, 91A, 91B, 92A, 92B are formed from a biocompatible material as described herein. In some examples, at least one of tip contacts 94, 96, 98 and / or contact rings 90A, 90B, 91A, 91B, 92A, 92B is anodized to provide an identifier. In one example, the tip contact is anodized to provide an identifier. That is, at least one of the tips 94, 96, 98 and / or the contact rings 90A, 90B, 91A, 91B, 92A, 92B is a lead wire label for the lead wires 27A-C. For example, at least one of tip contact 94 and / or contact rings 90A and 90B is anodized to provide color 51, and at least one of tip contact 96 and / or contact surfaces 91A and 91B is anodized to provide color 52. And at least one of tip contact 98 and / or contact surfaces 92A and 92B is anodized to provide color 53.

  FIG. 7 is a perspective view showing an example of the header 22 and the housing 18 of the IMD 12. As described herein, the header 22 can include a core 48 disposed within the header housing 46, which defines the holes 50A-C. In the example of FIG. 7, the header 22 includes an antenna 110 disposed along a portion of the core 48 at least partially within the header housing 46.

  The header 22 of FIG. 7 includes connector blocks 104A-B, 106A-D, 108 disposed within the connector block opening 68. FIG. The connector blocks 104A-B, 106A-D, 108 are electrically and mechanically coupled to at least one of the lead wires 27A-C. For example, connector blocks 104A-B, 106A-D, 108 are provided with contact rings 90A, 90B of lead wires 27A-C (shown in FIG. 6) when lead wires 27A-C are disposed in holes 50A-C. Provide contact surfaces that interact with 91A, 91B, 92A, 92B and tip contacts 94, 96, 98.

  In one example, the plurality of contact wires 112, 113, 114, 115, 116, 117, 118, 119 extend from the top 120 of the housing 18. The contact wires 112, 113, 114, 115, 116, 117, 118, and 119 are connected to the connector blocks 104 </ b> A to B, 106 </ b> A to D and 108, and the lead wires 27 </ b> A to 27 </ b> C are connected to the electric circuit 20 accommodated in the housing 18. Connect electrically. The example of FIG. 7 includes eight contact wires, but the number of contact wires depends on the type of IMD 12 and the treatment being provided. In one example, the number of contact wires varies between 2 and 32. In one example, the number of contact wires is greater than 32. However, as the number of contact wires increases, the risk of wire misconnection (eg, wire crossing) can also increase.

  In one example, at least one of the contact wires 112, 113, 114, 115, 116, 117, 118, 119 is anodized to include an identifier such as a color. For example, contact wires 115 and 117 are configured to couple to connector blocks 104A and 104B associated with hole 50A. Thus, contact wires 115 and 117 are anodized to include an identifier such as color 51 (eg, red). Thus, the operator easily visually recognizes that the contact wires 115 and 117 (having the color 51) are connected to the connector blocks 104A-B associated with the holes 50A (having the header label 40A including the color 51). be able to.

  In one example, contact wires 114, 116, 118, 119 are anodized to include an identifier such as color 52 (eg, blue). Thus, the operator confirms that contact wires 114, 116, 118, 119 (having color 52) are connected to connector blocks 106A-D that are associated with holes 50BA (having header label 40B that includes color 52). It can be easily visually recognized. Further, the contact wire 113 is anodized to include an identifier such as color 53 (eg, yellow). Thus, the operator easily visually confirms that the contact wire 113 (having the color 53) is connected to the connector block 108 associated with the hole 50C (having the header label 40C including the color 53). The contact wire 112 may not be anodized and may have a biocompatible metal color (eg, silver) prior to anodization.

  In one example, connector blocks 104A-B, 106A-D, 108 are anodized to include an identifier (eg, color) to further assist the operator or surgeon. For example, connector blocks 104A-B are anodized to have color 51, connector blocks 106A-D are anodized to have color 52, and connector block 108 is anodized to include color 53. The connector block is anodized in addition to or instead of the header labels 40A-C. In one example, the header labels 40A-C include only the strings “RV”, “RA”, “LV”, and the connector block includes colors 51, 52, 52.

  FIG. 8 shows an example of a method 200 for labeling an IMD. In describing the method 200, reference is made to features and elements already described herein, including reference numerals. Signed elements provided in the description of method 200 are not intended to be limiting, reference numerals are provided for convenience, and these elements are similar features described herein and equivalents thereof. including.

  The method 200 includes, at 202, connecting the first biocompatible metal substrate and the second biocompatible metal substrate to the core of the implantable medical device header. For example, the first biocompatible metal substrate and the second biocompatible metal substrate connect to the core 48 of the header 22 of the IMD 12. The core 48 can have a first hole 50A and a second hole 50B, the first biocompatible metal substrate being disposed adjacent to the first hole 50A, and the second biocompatible metal substrate being It arrange | positions adjacent to the 2nd hole 50B. For example, the metal substrates are header labels 40A and 40B as shown in FIG. The biocompatible metal substrate is connected as described herein with reference to FIGS. 3A and 3B. For example, a biocompatible metal substrate (for example, header labels 40A and 40B) is inserted into the accommodating gaps 70A and 70B.

  Method 200 includes forming core 48 to include a first receiving cavity (eg, containing cavity 70A) and a second receiving cavity (eg, containing cavity 70B). The first accommodating gap 70A is configured to accommodate a first biocompatible metal substrate (eg, header label 40A), and the second accommodating gap is configured to accommodate the second biocompatible metal substrate (eg, header label 40B). Configure to house.

  The method 200 can include, at 204, anodizing the first biocompatible metal substrate to include at least a first color, and at 206, a second biocompatible to include at least a second color. Anodizing the conductive metal substrate. As described herein, the first color and the second color are different from each other. In one example, an electrochemical anodization method is used. In another example, the first and second colors are provided using the LASER anodization method.

  Method 200 anodizes a first biocompatible metal substrate to include a first string and anodizes a second biocompatible metal substrate to include a second string. And the second character string is different from the first character string. For example, as shown in FIG. 4, the header label 40A is anodized so as to include the character string “RV”. In one example, the string is provided using the LASER anodization method. In one example, the strings can be contrasted with the first and second colors provided on the first and second biocompatible metal substrates by providing them in a color such as black.

  Anodization produces a variety of colors without the use of dyes or inks. Anodization provides an oxidized surface whose thickness is controlled on a visible light wavelength scale. The color formed depends on the thickness of the oxide layer, which is determined by various process factors. During electrochemical anodization, a voltage is applied to the electrolytic cell containing the components to produce a color. The applied voltage controls the color produced in the component by controlling the thickness of the oxide layer. During the LASER anodizing process, laser light passes through the surface of the metal substrate. Pulse rate, power (eg voltage), focal spot size, moving speed, laser speed, component mass, thermal conductivity, process atmosphere, thermal equipment, depth of focus, incident angle affect oxide layer thickness Controls the color generated in the component.

  The method 200 includes texturing the surface of the biocompatible metal substrate before or after anodizing the biocompatible metal substrate. The textured surface minimizes refraction so that the average color is presented to the viewer. The textured surface provides a more uniform and precise color that is independent of viewing angle. In one example, the biocompatible material is passed through a press with protrusions before or after anodization to provide a textured surface. In another example, the surface is textured using laser light used for anodization.

  As described herein, the method 200 includes anodizing the first biocompatible metal substrate before connecting the first biocompatible metal substrate and the second biocompatible metal substrate to the core; Anodizing the second biocompatible metal substrate. Alternatively, the method 200 includes anodizing the first biocompatible metal after connecting the first biocompatible metal substrate and the second biocompatible metal substrate to the core, and the second biocompatible metal. Including anodizing the substrate.

  In one example, the biocompatible metal substrate is anodized using an electrochemical anodization process to provide a color. The anodized biocompatible metal substrate is then connected to the header core. Once connected to the core, the biocompatible metal substrate is anodized using LASER anodization to provide a string.

  The method 200 includes, at 208, overmolding a core that includes a first biocompatible metal substrate and a second biocompatible metal substrate. For example, the core 48 including the biocompatible metal substrate (for example, the header labels 40 </ b> A to 40 </ b> C) is overmolded to form the header housing 46 of the header 22. That is, the header housing 46 is overmolded around the core 48 or otherwise formed.

  The method 200 includes connecting a first lead of the lead assembly to the first hole and connecting a second lead of the lead assembly to the second hole. For example, the lead wire 27A of the lead wire assembly 24 is connected to the hole 50A, and the lead wire 27B of the lead wire assembly 24 is connected to the hole 50B.

  The method 200 includes anodizing the first annular ring to include a first color and anodizing the second annular ring to include a second color. For example, the first annular ring 41A is anodized to form a color that is identical to the color 51 of the header label 40A (eg, color 51). Also, the second annular ring 41B is anodized to form a color that is the same as the color 52 of the header label 40B (eg, color 52). The method 200 includes connecting the first annular ring to the proximal end of the first lead 27A and connecting the second annular ring 41B to the proximal end of the second lead 27B. . For example, the annular rings 41A-C are connected to the leads 27A-C by interference fit or caulking. Further, the annular rings 41A to 41C are arranged in the circumferential grooves of the lead wires 27A to 27C. In one example, the lead wire labels 41A-C are integrated into the main body of the lead wires 27A-C. For example, annular metal rings (eg, lead wire labels 41A-C) are anodized and molded into the body of lead wires 27A-C with a transparent polymer material.

  The method 200 includes anodizing a first contact wire extending from a housing that includes an electronic circuit to include a first color, and a second contact extending from the housing to include a second color. Anodizing the wire. As described herein with respect to the example of FIG. 7, contact wires 112-119 are anodized to include color. Each color of the contact wires 112-119 assists the user in connecting the contact wires 112-119 to the header 22. For example, contact wires 115 and 117 are configured to connect to connector blocks 104A and 104B associated with hole 50A. Thus, contact wires 115 and 117 are anodized to include an identifier such as color 51 (eg, red). Contact wires 114, 116, 118, 119 are anodized to include an identifier such as color 52 (eg, blue). Further, contact wire 113 is anodized to include an identifier such as color 53 (eg, yellow).

  The method 200 includes connecting a first contact wire to a connector block disposed in the first hole and connecting a second contact wire to the connector block disposed in the second hole. Including. For example, contact wires 115 and 117 (eg, having color 51) connect to connector blocks 104A-B associated with holes 50A (eg, having header label 40A including color 51), and contact wires 114, 116, 118, 119 (eg, having color 52) can be connected to connector blocks 106A-D associated with holes 50BA (eg, having header label 40B including color 52), and contact wires 113 (eg, having color 53) are The connector block 108 is connected to the hole 50C (for example, having a header label 40C including the color 53).

  FIG. 9 shows an example of a method 300 for labeling an IMD. In describing the method 300, reference is made to features and elements already described herein, including reference numerals. Signed elements provided within the description of method 300 are not intended to be limiting, reference numerals are provided for convenience, and those elements are described by similar features described herein and their equivalents. including.

  The method 300 includes, at 302, connecting a first biocompatible metal substrate to a core of an implantable medical device header. For example, a biocompatible metal substrate (eg, header label 74) is connected to the core 48 as shown in FIG. 5A. The core 48 has a first hole 50A and a second hole 50B. The biocompatible metal substrate is connected to the core as described with reference to FIGS. 5A and 5B. For example, a biocompatible metal substrate (for example, header label 74) is inserted into the accommodation gap 76. The method 300 includes forming the core 48 to include a receiving cavity 76, wherein the first receiving cavity 76 is configured to receive a biocompatible metal substrate (eg, header label 76).

  The method 300 at 304 anodizes the first portion of the biocompatible metal substrate to include a first color, and at 306, the second of the biocompatible metal substrate to include a second color. Anodizing the portion. For example, header label 74 includes header label 74 portion 78 adjacent to hole 50A having color 51 and header label 74 portion 80 adjacent to hole 50B having color 52 and header label adjacent to hole 50C. 74 portions 82 are selectively anodized to have color 53.

  As described herein, the method 300 includes anodizing a first portion of the biocompatible metal substrate before connecting the biocompatible metal substrate to the core, and a second portion of the biocompatible metal substrate. Anodizing the portion. In one example, the first and second portions of the biocompatible metal substrate are anodized using an electrochemical anodization process to provide color.

  Optionally, the method 300 at 308 anodizes the first portion of the biocompatible metal substrate to include the first string, and at 310, the biocompatible to include the second string. Anodizing the second portion of the metal substrate. Method 300 includes anodizing the first and second portions of the biocompatible metal substrate, respectively, to include the first and second strings after connecting the biocompatible metal substrate to the core. In one example, the first and second portions of the biocompatible metal substrate are anodized to provide a string using the LASER anodization method as described herein.

The method 300 includes, at 312, overmolding a core that includes a biocompatible metal substrate. For example, a core 48 including a biocompatible metal substrate (eg, header label 74) is overmolded to form the header housing of the header 22. That is, the header housing is overmolded around the core 48 or otherwise formed as described herein.
Additional Notes and Examples Example 1 is a housing including an electronic circuit and a header coupled to the housing and including a core, wherein the core defines a hole and is disposed adjacent to the at least one hole. A lead assembly including a header including one metal label and at least one lead having a distal end and a proximal end, the at least one lead including a second metal label, the distal end Including an implantable medical device comprising: a lead assembly including at least one electrode and a proximal end received in the hole.

  Example 2 includes the invention of Example 1 such that the first metal label and the second metal label optionally include at least one selected from titanium, tantalum, tungsten, and stainless steel. Or, optionally combined with the invention of Example 1.

  Example 3 optionally includes that the first metal label includes a first identifier, the second metal label includes a second identifier, and the first identifier is substantially the same as the second identifier. Thus, one or any combination of the embodiments 1 to 2 is included or arbitrarily combined with the invention.

  Embodiment 4 includes the invention of one or any combination of Embodiments 1 to 3 so that the first identifier and the second identifier optionally include at least one of a color and a character string. Including or optionally combining with the invention.

  Example 5 optionally includes that the first identifier is the first color, the second identifier is the second color, and the second color and the first color are substantially the same. Including one or any combination of the inventions of Examples 1 to 4 or any combination thereof.

  Example 6 includes, or includes, the invention of one or any combination of Examples 1 to 5 so that the first metal label optionally includes an anodized metal substrate. Combine arbitrarily.

  Example 7 includes, or includes, the invention of one or any combination of Examples 1-6, optionally including that the surface of the anodized metal substrate is textured. Combine arbitrarily.

  Example 8 of Examples 1-7, wherein the surface of the core defines a receiving cavity adjacent to the hole, and optionally includes the receiving cavity being configured to receive the first metal label. Including, or optionally combined with, one or any combination of inventions.

  Example 9 includes the invention of one or any of Examples 1-8 or any combination thereof, so that the second metal label optionally includes an anodized metal annular ring. Optionally combined with the invention.

  Example 10 includes the invention of one or any of Examples 1-9, or any combination thereof, so as to optionally include that the outer surface of the anodized metallic annular ring is textured Optionally combined with the invention.

  Example 11 includes the invention of one or any combination of Examples 1-10, such that the outer surface of the lead optionally includes defining a circumferential groove that accommodates the second metal label. Or arbitrarily combined with the invention.

  Example 12 includes or is optionally combined with one or any of the inventions of Examples 1 to 11 so that the core optionally includes being overmolded with a dielectric material.

  Example 13 includes the invention of one or any of Examples 1-12, optionally including at least a portion of a lead having a second metal overmolded with a dielectric material. Including or optionally combining with the invention.

  Example 14 is a housing that includes an electronic circuit, wherein a first contact wire and a second contact wire extend from the housing, the first contact wire includes a first identifier, and the second contact wire Including a second identifier, a header connected to the housing and including a core defining a first hole and a second hole, a first connector block in communication with the first hole, and a second A second connector block in communication with the hole; a first anodized metal label disposed adjacent to the first hole; and a second anodized metal disposed adjacent to the second hole. A lead wire assembly including a first metal wire, a first lead wire, and a second lead wire, wherein the first lead wire is electrically connected to the electronic circuit via the first connector block; 2 lead wires through the second connector Including invention including an implantable medical device comprising: a lead assembly that is electrically connected to the road, the.

  Example 15 of Examples 1-14, wherein the first contact wire is anodized to provide a first identifier, optionally including that the first identifier is a first color. It includes, or is optionally combined with, one or any combination of inventions.

  Example 16 is an example in which the second contact wire is anodized to provide a second identifier, optionally including that the second identifier is a second color different from the first color. It includes, or is optionally combined with, one or any combination of the inventions 1-15.

  Example 17 includes the invention of one or any combination of Examples 1-16, or alternatively, such that the first anodized metal label optionally includes a first color. Optionally combined with the invention.

  Example 18 includes the invention of one or any combination of Examples 1-17 or any combination thereof such that the second anodized metal label optionally includes a second color. Optionally combined with the invention.

  Example 19 is an example in which the first connector block is anodized to include a first color, and the second connector block is optionally anodized to include a second color. It includes, or is optionally combined with, one or any combination of inventions 1-18.

  Example 20 is an example that optionally includes the first anodized metal label and the second anodized metal label being an anodized metal substrate that is bonded to the surface of the core. 1 to 19 of any one or any combination of inventions is included or optionally combined with the invention.

  Example 21 includes inventions such as a method of labeling an implantable medical device. The method includes connecting a first biocompatible metal substrate and a second biocompatible metal substrate to a core of an implantable medical device header, the core being a first hole and a second hole. The first biocompatible metal substrate is disposed adjacent to the first hole, the second biocompatible metal substrate is disposed adjacent to the second hole, and at least a first color Anodizing the first biocompatible metal substrate to include, and anodizing the second biocompatible metal substrate to include at least a second color, wherein the second color is Differing from the first color and overmolding a core comprising a first biocompatible metal substrate label and a second biocompatible metal substrate.

  In Example 22, anodizing the first biocompatible metal substrate and anodizing the second biocompatible metal substrate include the first biocompatible metal substrate and the second biocompatible metal substrate. Including, or optionally combining with, the invention of one or any combination of Examples 1-21 to optionally include what is performed prior to joining the metal substrate to the core.

  In Example 23, anodizing the first biocompatible metal substrate and anodizing the second biocompatible metal substrate are performed using at least one of electrochemical anodization and LASER anodization. It includes or is optionally combined with one or any combination of the inventions of Examples 1-22 to optionally include what is performed.

  Example 23 optionally includes connecting the first lead of the lead assembly to the first hole and connecting the second lead of the lead assembly to the second hole. Including any invention of any one or any combination of Examples 1-22, or any combination thereof.

  Example 24 includes anodizing the first annular ring to include the first color, anodizing the second annular ring to include the second color, and the first annular ring. To the proximal end of the first lead and optionally connecting a second annular ring to the proximal end of the second lead. It includes, or is optionally combined with, one or any combination of the inventions.

  Example 25 is to form the core so as to include the first accommodation gap and the second accommodation gap, and the first accommodation gap is configured to accommodate the first biocompatible metal substrate. Including the invention of one or any combination of Examples 1 to 24, optionally including that the second receiving cavity is configured to receive the second biocompatible metal substrate, Or arbitrarily combined with the invention.

  Example 26 includes anodizing a first contact wire that extends from a housing that includes an electronic circuit to include a first color, and a second that extends from the housing to include a second color. Anodizing the contact wire; connecting the first contact wire to a connector block disposed in the first hole; and a connector block disposed in the second hole. Including, or optionally combining with, the invention of one or any combination of embodiments 1 to 25, so as to optionally include connecting.

  In Example 27, the first biocompatible metal substrate is anodized to include the first character string, and the second biocompatible metal substrate is anodized to include the second character string. And any one or any combination of the embodiments 1-26, or optionally in combination with the invention, so that the second string is optionally different from the first string. .

  Example 28 includes anodizing the first biocompatible metal substrate to include the first color and anodizing the second biocompatible metal substrate to include the second color. Anodizing the first biocompatible metal substrate to include a first character string, performed using an electrochemical anodization method, and a second biocompatible to include a second character string Including or optionally combining one or any of the inventions of Examples 1-27, optionally including anodizing the metal substrate is optionally performed using the LASER anodization method.

A method of labeling an implantable medical device.
Example 29 includes inventions such as a method of labeling an implantable medical device. The method connects a biocompatible metal substrate to a core of an implantable medical device header, the core having a first hole and a second hole, and biocompatible so as to include a first color. Anodizing the first portion of the conductive metal substrate and anodizing the second portion of the biocompatible metal substrate to include a second color, wherein the second color is the first Unlike the color, the first portion of the biocompatible metal substrate is disposed adjacent to the first hole, and the second portion of the biocompatible metal substrate is disposed adjacent to the second hole; Overmolding a core comprising a first biocompatible metal substrate label and a second biocompatible metal substrate.

Each of these non-limiting examples is independent or combined in various substitutions or combinations with one or more of the other examples.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments for carrying out the invention. These embodiments are shown as “Examples”. Such embodiments include elements other than those shown or described. However, the inventors also contemplate embodiments in which only the elements shown or described are provided. Furthermore, the inventors have directed to specific embodiments (or one or more aspects thereof) or other embodiments (or one or more aspects thereof) illustrated or described herein. Embodiments are contemplated using any combination or permutation of the elements shown or described (or one or more aspects thereof).

In the event of a conflict between this specification and any document incorporated by reference, the use herein shall prevail.
As used herein, the word “a” or “an” is used regardless of any other “at least one” or “one or more” case or use, as is common in patent documents. Used to include one or more. As used herein, the term “or” is non-exclusive, ie, “A or B” is “A but not B”, “B but not A”, “A and B, unless otherwise specified. "including. In the present specification, the words “including” and “in what” are used as plain English equivalent to the words “comprising” and “wherein”, respectively. Also, in the following claims, the terms “including” and “comprising” are open-ended. That is, a system, apparatus, product, composition, formulation, or process that includes elements other than those listed after the wording in the claims is also considered to be within the scope of the claims. Further, in the following claims, the words “first”, “second”, “third”, etc. are merely used as indicators and are not intended to impose numerical requirements on the subject.

  The above description is illustrative and not intended to be limiting. For example, the above-described examples (or one or more aspects thereof) are combined with each other. After referring to the above description, other embodiments can be used by those skilled in the art. The abstract is provided in compliance with 37 CFR 1.72 (b) so that the reader can quickly recognize the nature of the technical disclosure. The Abstract is provided with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above detailed description, various features are grouped to simplify the present disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. The invention of the invention resides in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description as examples or embodiments, and each claim is independent as a separate embodiment, and such embodiments are combined with each other in various combinations or substitutions. . The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims (13)

A housing containing electronic circuitry;
A header coupled to the housing and including a core, the header including a first metal label that defines a hole and is disposed adjacent to the at least one hole;
A lead assembly including at least one lead having a distal end and a proximal end, wherein the at least one lead includes a second metal label and the distal end includes at least one electrode. A lead assembly in which the proximal end is received in the hole;
An implantable medical device. The implantable medical implant according to claim 1, wherein the first metal label and the second metal label are selected from at least one of titanium, tantalum, tungsten, and stainless steel. The first metal label includes a first identifier, the second metal label includes a second identifier, and the first identifier is substantially the same as the second identifier. The implantable medical implant according to 1. The implantable medical implant according to any one of claims 1 to 3, wherein the first identifier and the second identifier include at least one of a color and a character string. 5. The device according to claim 1, wherein the first identifier is a first color, the second identifier is a second color, and the second color and the first color are substantially the same. An implantable medical implant according to claim 1. The implantable medical implant according to any one of claims 1 to 5, wherein the first metal label is an anodized metal substrate. The implantable medical implant according to claim 6, wherein a surface of the anodized metal substrate is textured. Implantation according to any one of the preceding claims, wherein the surface of the core defines a receiving cavity adjacent to the hole, the receiving cavity being configured to receive the first metal label. Type medical implant. The implantable medical implant according to any one of claims 1 to 8, wherein the second metal label is an anodized metal annular ring. The implantable medical implant according to claim 9, wherein an outer surface of the anodized metal annular ring is textured. The implantable medical implant according to any one of the preceding claims, wherein an outer surface of the lead wire defines a circumferential groove configured to receive the second metal label. The implantable medical implant according to any one of claims 1 to 11, wherein the core is overmolded with a dielectric material. The implantable medical implant according to any one of claims 1 to 12, wherein at least a portion of the lead having the second metal label is overmolded with a dielectric material.